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HPV-related Oropharyngeal and Uncommon Cancers Screening

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ClinicalTrials.gov Identifier: NCT02897427
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and uncommon cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.

Condition or disease Intervention/treatment
Health Status Unknown Other: Biomarker Analysis Procedure: Biospecimen Collection Procedure: Ultrasonography

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Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Official Title: HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial of meN (HOUSTON Study)
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 28, 2027
Estimated Study Completion Date : March 28, 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
Screening (specimen collection, HPV testing)

STAGE I: Participants undergo collection of blood and oral gargle samples.

STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, undergo collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood.

 Other: Biomarker Analysis
Complete HPV testing

Procedure: Biospecimen Collection
Undergo collection of blood, oral gargle, and oral rinse samples

Procedure: Ultrasonography
Undergo transcervical ultrasonography
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • ULTRASOUND
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US


Outcome Measures
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Primary Outcome Measures :
  1. Cancer detection rate of the seropositive group [ Time Frame: Up to 5 years ]
    Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.

  2. Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens [ Time Frame: Up to 5 years ]
    Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
MDACC Participants
Criteria

Inclusion Criteria:

  • United States (US) resident
  • Fluent in English
  • Sign an approved informed consent document

  • Stage 2 (longitudinal study) Inclusion Criteria:

    • Eligible for and enrolled in Stage 1
    • Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
    • Sign an approved informed consent document

Exclusion Criteria:

  • Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
  • Received radiation cancer therapy to the head and neck in the past
  • On active cancer therapy now or in the past 6 months
  • Ever had a transplant (stem cell, bone marrow, or solid organ)
  • Patients who received blood transfusions in the last 6 months
  • Other medical or psychiatric illness or social situation that would limit study compliance
  • Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897427


Contacts
Contact: Erich Sturgis 713-792-6920 :esturgis@mdanderson.org

Locations
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Erich M. Sturgis    713-792-6920      
Principal Investigator: Erich M. Sturgis         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Erich Sturgis M.D. Anderson Cancer Center
More Information
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Additional Information:
MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02897427     History of Changes
Other Study ID Numbers: 2016-0109
NCI-2018-02604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0109 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No